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    Summary
    EudraCT Number:2021-000639-30
    Sponsor's Protocol Code Number:AB20009
    National Competent Authority:Germany - BfArM
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2022-01-24
    Trial results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedGermany - BfArM
    A.2EudraCT number2021-000639-30
    A.3Full title of the trial
    A 96-Week, Prospective, Multicenter, Randomised, Double-Blind, PlaceboControlled, Phase 3 Study to Compare Efficacy and Safety of Masitinib Dose Titration to 4.5 mg/kg/day versus Placebo in the Treatment of Patients with Primary Progressive or Secondary Progressive Multiple Sclerosis Without Relapse
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A phase 3 study to compare efficacy and safety of masitinib with placebo in the patients with primary progressive or secondary progressive multiple sclerosis without relapse.
    A.4.1Sponsor's protocol code numberAB20009
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorAB Science
    B.1.3.4CountryFrance
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportAB Science
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAB Science
    B.5.2Functional name of contact pointAlain Moussy
    B.5.3 Address:
    B.5.3.1Street Address3 avenue George V
    B.5.3.2Town/ cityParis
    B.5.3.3Post code75008
    B.5.3.4CountryFrance
    B.5.4Telephone number0033147202311
    B.5.5Fax number0033147202411
    B.5.6E-mailregulatoryaffairs@ab-science.com
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameMasitinib
    D.3.2Product code AB1010
    D.3.4Pharmaceutical form Film-coated tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNMasitinib mesilate
    D.3.9.1CAS number 790299-79-5
    D.3.9.2Current sponsor codeAB1010
    D.3.9.4EV Substance CodeSUB32266
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.IMP: 2
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameMasitinib
    D.3.2Product code AB1010
    D.3.4Pharmaceutical form Film-coated tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNMasitinib mesilate
    D.3.9.1CAS number 790299-79-5
    D.3.9.4EV Substance CodeSUB32266
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number200
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboFilm-coated tablet
    D.8.4Route of administration of the placeboOral use
    D.8 Placebo: 2
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboFilm-coated tablet
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Patients with primary progressive or secondary progressive multiple sclerosis without relapse
    E.1.1.1Medical condition in easily understood language
    Multiple sclerosis
    E.1.1.2Therapeutic area Diseases [C] - Nervous System Diseases [C10]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level PT
    E.1.2Classification code 10063400
    E.1.2Term Secondary progressive multiple sclerosis
    E.1.2System Organ Class 10029205 - Nervous system disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level PT
    E.1.2Classification code 10063401
    E.1.2Term Primary progressive multiple sclerosis
    E.1.2System Organ Class 10029205 - Nervous system disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To evaluate the efficacy and safety of oral masitinib versus placebo in the
    treatment of patients with primary progressive or secondary progressive multiple
    sclerosis without relapse.
    E.2.2Secondary objectives of the trial
    The secondary objectives of the study are to evaluate the efficacy of masitinib compared with placebo on a range of clinical parameters of multiple sclerosis. The secondary objectives also include the assessment of safety and tolerability of masitinib as compared to placebo in terms of adverse events, vital signs, physical examination, ECG, and clinical laboratory tests.
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    Sub-study: Serum Neurofilament Light Chain (NfL) and GFAP
    Comparison of serum Neurofilament Light Chain (NfL) and GFAP levels at
    Baseline and W96 / end of treatment or early termination (only if patient
    discontinues after 48 week and more than 24 weeks have elapsed since last tests).

    Biomarker Sub-study (on a subgroup of 200 patients of pre-selected sites): Serum biomarkers NfL and GFAB at baseline, week 48 and week 96/early termination if more
    than 24 weeks elapsed since last sample collection.
    E.3Principal inclusion criteria
    Inclusion Criteria
    Related to disease
    1. Patients with either primary progressive or secondary progressive
    multiple sclerosis with onset of symptoms at least five years before
    baseline and with no relapse diagnosed according to the 2017 revised
    McDonald’s criteria at least two years before screening
    2. Patients with Expanded Disability Status Scale (EDSS) score between 3.0 to 6.0 (both inclusive) at screening and baseline
    3. Patients with an EDSS score progression ≥1 point with no improvement during 2 years before screening
    4. Absence of T1 Gadolinium-enhancing brain lesions as measured by MRI at screening

    Other inclusion criteria
    5. Male or female patients aged between 18 and 65 years at screening
    6. Weight >45 kg and BMI between 18 and 35 kg/m2 at screening and baseline
    7. Contraception, to be assessed at screening and at baseline:
    Female patients of childbearing potential (entering the study after a menstrual period and who has a negative pregnancy test), who agrees to use a highly effective method of contraception and an effective method of contraception by her male partner during the study and for 3 months and a
    half after the last treatment intake

    Male patients with a female partner of childbearing potential who agrees to use a highly effective method of contraception and an effective method of contraception by his female partner during the study and for 3 months and a half after the last treatment intake OR who agrees to use an effective method of contraception and a highly effective method of contraception by his female partner during the study and for 3 months and a half after the last treatment intake

    Highly effective and effective methods of contraception are detailed in the
    Appendix 14.1 of the protocol.

    8. Patients able to understand, and willing to sign, and date the written informed consent form prior to any protocol-specific procedures, at screening. If patients are duly capable of study consent but are unable to sign by themselves due to aggravation of disease condition, written informed consent can be obtained from a legally authorized representative who can sign on behalf of the patients after confirming the patients' agreement to study participation
    9. Patients able and willing to comply with study protocol and to come onsite
    as per protocol visits schedule, assessed at screening and at baseline.



    E.4Principal exclusion criteria
    Exclusion Criteria:
    Related to disease
    1. Patients suffering from a disease other than MS that would better explain the patient’s neurological clinical signs and symptoms and/or MRI lesions observed at screening
    2. Inability to complete screening MRI (contraindications for MRI) and/or
    any known allergy or hypersensitivity or any contra-indication to
    gadolinium macrocyclic
    3. Patients treated with other disease modifying treatments in the time
    frames and conditions mentioned under previous treatment wash out
    period, assessed at baseline
    4. Patients with lymphocytes <1.0 × 109/L at screening and at baseline

    Other exclusion criteria
    5. Patients with hypersensitivity to masitinib or its excipients at screening
    6. Patients with history (or family history) of severe skin toxicities or reactions at screening or patients taking concomitant treatment or therapies associated with severe drug-induced skin toxicity at screening and baseline
    7. Patients with history of severe bone marrow disorders such as agranulocytosis or aplasia, or with abnormal laboratory results at screening and baseline defined as:
    - Neutropenia with ANC <1.5 × 109/L
    - Anemia with Hgb <10 g/dl
    - Thrombocytopenia with platelet counts <75 × 109/L
    8. Patients with history of severe hepatic disorders, such as viral hepatitis or steatohepatitis, and alcohol steatosis, or with abnormal laboratory results defined as:
    - Hepatic transaminase levels >2 ULN at baseline, or
    - Total bilirubin level >1.5 ULN at baseline, or
    - Both hepatic transaminase levels and total bilirubin level outside of
    the normal ranges at screening and baseline, or
    - Albuminemia <1 × LLN at screening and baseline, or
    - Patients with concomitant medication known to be associated with severe hepatotoxicity
    9. Patients with pre-existing severe renal impairment, or with abnormal laboratory results at screening:
    - Creatinine clearance <60 mL/min (Cockcroft and Gault formula) or
    - Proteinuria >30 mg/dL (1+) on dipstick; in case of the proteinuria ≥1+ on the dipstick, 24 hours proteinuria must be >1.5 g/24 hours
    10. Patients with current or history of severe cardiovascular disease, assessed
    at screening:
    - Myocardial infarction
    - Unstable angina pectoris
    - Coronary revascularization procedure
    - Congestive heart failure of NYHA Class III or IV
    - Stroke, including a transient ischemic attack
    - Second degree or third-degree atrioventricular block not successfully treated with a pacemaker
    - Bi-fascicular block
    - QTc Fridericia interval >450 milliseconds for males and >470 milliseconds for females
    - Drug induced heart failure or ischemic heart disease
    - Radiotherapy induced cardiomyopathy
    - Family history of unexpected death of cardiovascular origin
    - Edema of cardiac origin and left ventricular ejaculation fraction ≤50%
    11. Patients, with two or more of the risk factors listed below assessed by a cardiologist at screening as Very High Risk (calculated SCORE* ≥10%.) or High Risk (calculated SCORE* ≥5% and <10%) according to the Systematic Coronary Risk Estimation (SCORE):
    - Hypertension (uncontrolled) ; - Diabetes; - Kidney disease; - Current tabagism (≥ 10 Pack-year: equivalent to 1 pack of 20 cigarettes for 10 years with the formula N (number of packs of 20 cigarettes smoked daily) × T (number years smoking)) Patients who stopped smoking 6 months prior to the evaluation, are not concerned.
    - Hypercholesterolemia,
    - Chronic obstructive pulmonary disease (COPD)
    * This assessment is done according to the Systematic Coronary Risk Estimation (SCORE) using the country specific free full version of HeartScore®
    , the interactive tool for predicting and managing the risk of heart attack and stroke in Europe, available at https://www.heartscore.org/en_GB/access
    If the country specific version is not available, EU one should be used.
    12. Patients with active severe infection such as tuberculosis, viral hepatitis, human immunodeficiency virus infection, syphilis or COVID-19 (confirmed by positive RT-PCR and/or other applicable methods), assessed at screening or baseline.
    13. Patient treated concomitantly with known substrates of PermeabilityGlycoProtein (P-gp) and/or Breast Cancer Resistance Protein (BCRP) with narrow therapeutic index.
    14. Any medical condition at screening and baseline that, in the opinion of the Investigator, might interfere with the patients’ participation in the trial, poses any added risk for the patients, or confounds the assessment of the patients
    15. Patients under psychiatric care, patients protected by law under
    guardianship or curatorship, patients in emergency situations, prisoners
    and patients without national health insurance at screening and baseline.
    16. Patients who had major surgery within 2 weeks prior to screening visit
    17. Pregnant, or nursing female patients at screening or baseline.

    Exclusion Criteria 18-21 please refer to the protocol (p. 6)
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint is to assess the efficacy of masitinib 3.0 mg/kg/day with a dose escalation to 4.5
    mg/kg/day after four weeks on the time to confirmed (12-weeks CDP) EDSS progression. Progression
    is defined as 1-point worsening when EDSS score ≤5.5, or 0.5-point worsening if baseline score >5.5.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Week 96
    E.5.2Secondary end point(s)
    The secondary endpoints of the study include the following:
    Expanded Disability Status Scale (EDSS):
    • Time to confirmed (24-weeks CDP) EDSS progression. Progression is defined as 1-point worsening when EDSS score ≤5.5, or 0.5 if baseline score >5.5)
    • Expanded Disability Status Scale (EDSS): Absolute and ordinal change from baseline considering all measurements up to Week 96
    • Time to EDSS score of 7.0

    Clinical Global Assessment Tools:
    • Timed 25-foot walk (T25-FW) from baseline up to Week 96 and 12 weeks confirmed worsening using 20% threshold
    • Nine-hole peg test (9-HPT), right and left hands sides (finger dexterity) from baseline up to Week 96 and 12 weeks confirmed worsening using 20% threshold
    • The Symbol Digit Modalities Test (SDMT) from baseline up to Week 96 and 12 weeks confirmed worsening using 4-point threshold

    Brain MRI Assessments:
    • Brain Volume and Lesions will be measured and assessed at Baseline, Week 48 and Week 96, or early termination (only if patient discontinues after Week 48 and more than 24 weeks have elapsed since last MRI) for the following endpoints: Brain atrophy - Percent brain volume change (PBVC) from baseline at Week 96 or early termination
    • New/newly enlarged T2 lesion count (compared with baseline MRI scan) at Week 96 or early termination

    Quality of Life assessment:
    • Quality of life assessment: Multiple Sclerosis Quality of Life (MSQOL)-54 instrument from baseline up to Week 96
    • Modified Fatigue Impact Scale (MFIS) from baseline up to Week 96
    • Hamilton Depression Rating Scale (HAM-D) from baseline up to Week 96
    • Disability Impact Profile (DIP) from baseline up to Week 96

    Relapses:
    • Occurrence of new or worsening neurological symptoms attributable to MS
    • Symptoms persisting for >24 hours
    • Symptoms not attributable to confounding clinical factors (e.g., fever, infection, injury, adverse reactions to medications)
    • Symptoms immediately preceded by a stable or improving neurological state for at least 30 days
    • Symptoms accompanied by objective neurological worsening consistent with an increase of at least half a step on the EDSS scale

    Biomarker(s):
    • Comparison of serum Neurofilament Light Chain (NfL) and Glial Fibrillary Acidic Protein (GFAP) levels at Baseline and Week 96 or early termination (only if patient discontinues after Week 48 and more than 24 weeks have elapsed since last test)
    These biomarkers are to be tested in a subgroup of 200 patients of pre-selected sites

    Elevated blood concentrations of Comparison of serum Neurofilament Light Chain (NfL) were found to correlate with an increase in the number of relapses, disability worsening, MRI disease activity and brain volume loss in Multiple Sclerosis (MS). Glial Fibrilliary Acidic Protein (GFAP) is the major intermediate cytoskeletal protein of astrocytes and that of axons may be released into the cerebrospinal fluid (CSF) during pathological processes in the central nervous system (CNS). GFAP, is a marker for astrogliosis and a potential biomarker for MS progression.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Week 96
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial2
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned9
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA75
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Canada
    Israel
    South Africa
    United States
    Finland
    France
    Poland
    Sweden
    Bulgaria
    Spain
    Germany
    Greece
    Italy
    Hungary
    Portugal
    Russian Federation
    Ukraine
    United Kingdom
    E.8.7Trial has a data monitoring committee Yes
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    The end of study is defined as the date of the last visit of the last patient undergoing the trial (LVLS)
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years1
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 720
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 80
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state20
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 720
    F.4.2.2In the whole clinical trial 800
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    None
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2022-08-09
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2022-12-16
    P. End of Trial
    P.End of Trial StatusOngoing
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